Diabetes mellitus is one of the leading causes of morbidity and mortality in the United States. Although the disease, once diagnosed, can be controlled, the diabetic patient faces many complications, some of them life-threatening. For example, the average life expectancy of the diabetic patient is one third less than that of the general population; blindness is twenty five times as common, renal disease is seventeen times more common, gangrene is five times as common and heart disease is twice as common in diabetics as compared to the non diabetic.
In addition, the incidence of this disease appears to be increasing--between 1936 and 1978 there was a six fold increase in the prevalence of the disease.
It is believed by many researchers in the field that many complications suffered by diabetic patients can be minimized or avoided by early detection of the onset of the disease and proper long-term control of the patient's blood glucose.
Unfortunately, prior art detection and monitoring methods have been unable to either accurately detect the onset of the disease at an early stage or assess the degree of control on a long-term basis. Such prior art detection methods, other than interpretation of clinical symptoms, rely on blood sugar measurements which reflect the presence of the disease. Prior art monitoring methods involve either spot blood sugar measurements or more complicated blood tests which reflect blood glucose levels that existed in the patient's body at a time three to five weeks prior to the time of measurement. Both prior art measurement methods require bodily invasion and the results are difficult to interpret.
Accordingly, it is an object of this invention to detect the onset of diabetes mellitus prior to the appearance of clinical symptoms.
It is another object of this invention to detect the development of diabetic eye disease.
It is still another object of this invention to assess the effectiveness of various methods of diabetic treatment.
It is yet another object of this invention to determine the relationship and degree of control required to prevent the occurrence of diabetic complications.
It is a further object of this invention to provide a method for objectively quantifying the effects of systemic disease, trauma, drugs, local inflammatory conditions of the eye, and aging.